Therefore, HEITEC has once again demonstrated its high standards of quality and safety, as well as the efficiency of its processes, and is prepared for the ever-increasing requirements of the global medical technology industry.

The EN ISO 13485 standard describes the requirements that must be met to fulfill the quality demands of specific customer and other products and services for the development and manufacture of medical devices. Among other things, the standard defines the assurance of appropriate resources, proper supplier selection, development, production, and service processes, as well as quality assessment. The new EN ISO 13485:2016 standard complements, strengthens, and specifies some of these requirements. For example, the preparation for verification and validation, as well as revalidation, will be more strictly regulated in the future. Risk management, traceability, and software validation will become even more important. In particular, with regard to the new European Medical Device Regulation (MDR), EN ISO 13485:2016 certification is an important prerequisite.

Furthermore, the company has successfully passed the inspection carried out by the US FDA (Food and Drug Administration), which ideally complements existing European certifications and demonstrates the quality system necessary to access the US market.

To be recognized as an accredited distributor, the German Federal Aviation Authority (Luftfahrtbundesamt) has, since March 2018, extended the reliability check of a company's security officer to all employees, processes, and procedures whose activities have a direct impact on air traffic safety. HEITEC has successfully passed the examination and has therefore demonstrated the safe handling of its delivery activities.

With these certifications, the Eckental branch complies with all the necessary regulations to serve international markets, and customers can be confident that their solutions can be designed, manufactured and marketed in accordance with all required guidelines.